Study of the Administration of a Food Supplement in Patients With Lithiasis Treated With Extracorporeal Shock Wave Lithotripsy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-22

Study Completion Date

2022-10-05

Brief Summary

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The extracorporeal shock wave lithotripsy (ESWL) is the treatment of choice for most stones in any of their locations. It is about breaking the stone without surgically intervening on the patient and getting him to expel the fragments himself.

It is thought that additional treatments to the ESWL could improve the success rate of ESWL for less favorable stones.

The components of our authorized food supplement have shown an inhibitory effect in vitro on the growth of calcium oxalate monohydrate crystals, even in hightly supersaturared solutions. Also these components show an inhibitory effect on the growth of calcium phosphate crystals. To sum up, it reduces the formation, inhibits the growth and promotes the dissolution of calcium oxalate and calcium phosphate kidney stones.

This is the reason why this experimental study aims to modify the size limit of the stones in the ESWL with adjuvant food supplement.

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Detailed Description

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The study treatment will be administered for 10 weeks. First, one dose will be administered every 12 hours for each patient during the 4 weeks prior to ESWL. After ESWL, and for 6 weeks, one dose will be administered every 24 hours.

Conditions

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Lithiasis Nephrolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Food supplement

Two doses (sachets) a day during 4 weeks before the ESWL. After the ESWL, one dose a day during 6 weeks.

Group Type EXPERIMENTAL

Food supplement

Intervention Type DIETARY_SUPPLEMENT

FagolitosPlus® is an authorized food supplement that contains hydroxycitric acid, vitamin complexes and ions.

Placebo

Two doses (sachets) a day during 4 weeks before the ESWL. After the ESWL, one dose a day during 6 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo has a composition that makes the weight and organoleptic characteristics are identical to FagolitosPlus®.

Interventions

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Food supplement

FagolitosPlus® is an authorized food supplement that contains hydroxycitric acid, vitamin complexes and ions.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo has a composition that makes the weight and organoleptic characteristics are identical to FagolitosPlus®.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Renal lithiasis with high radiological and clinical suspicion of calcium oxalate or calcium phosphate, size of the largest diameter between 1.5x1cm and 2x1cm, which will be treated by ESWL, being symptomatic with little probability of spontaneous expulsion.
* Signed informed consent to participate in the clinical study.

Exclusion Criteria

* Lithiasis of more than 20 mm and less than 15 mm for the largest diameter.
* Taking medications with influence on urinary lithogenesis (citrate, bicarbonate, thiazides, bisphosphonates, magnesium, calcium, vitamin B6, vitamin D, vitamin A, xanthine-oxidase inhibitors, uricosurics, probiotics, urease inhibitors, cystine binders, topiramate , antiretrovirals).
* Taking medications that influence urine pH (citrate, bicarbonate, carbonic anhydrase inhibitors, L-methionine, vitamin C, ammonium chloride).
* Taking selective serotonin reuptake inhibitor antidepressant medications.
* Taking anticoagulants and antiaggregants.
* ESWL contraindications: urine infection, active or recurrent; hemorrhagic diathesis; pregnant or lactating patients; others (extreme obesity, arterial aneurysm near the location of the stone, etc.).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No